The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Piper, Model Number Uds-piperb.
Device ID | K951805 |
510k Number | K951805 |
Device Name: | PIPER, MODEL NUMBER UDS-PIPERB |
Classification | Device, Cystometric, Hydraulic |
Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
Contact | Fred Buffa |
Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario), CA L4v 1x1 |
Product Code | FEN |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-18 |
Decision Date | 1995-07-06 |